Type 1 Diabetes

Cancer drugs cure Type 1 diabetes in mice

John Carroll — Tue, 18 Nov 2008 10:40:03 -0500

A team of scientists from Plexxikon and UC San Francisco say they were able to eliminate symptoms of Type 1 diabetes in mice by treating them with Gleevec and Sutent, two well known cancer drugs. In a study published in the Proceedings of the National Academy of Sciences, the scientists say they were also able to delay disease progression by giving the genetically modified mice daily treatments of Gleevec. Report

Inhaled insulin shows signs of life after setbacks

John Carroll — Tue, 16 Sep 2008 12:01:22 -0400

Mannkind took another big step toward filing an application for its inhaled insulin after releasing data from a late-stage trial demonstrating the therapy is not inferior to injected drugs that control blood sugar levels in Type 1 diabetes patients. Just as importantly, researchers noted that there was no difference in lung function measures for patients taking Mannkind's therapy, a safety factor that has dogged similar therapies.

Mannkind has stuck with its inhaled insulin program even after Pfizer, Eli Lilly and Novo Nordisk had all walked away from their own efforts in the field. In a separate announcement Pfizer said that some Exubera patients who still need an inhaled insulin will be switched to Mannkind's therapy. Investors have battered the company's stock price, but the CEO says Mannkind plans to go the distance.

"Technosphere Insulin promises to be an important additional option for the treatment of patients with Type 1 diabetes," MannKind Chief Scientific Officer Peter Richardson said in a statement. An application should follow in the next few months.

- check out the Mannkind release
- read the story from the Wall Street Journal

ALSO NOTED: ASCO already churning out news; Lilly, FDA ironing out Zyprexa shot problems; and much more...

Fri, 30 May 2008 06:59:50 -0400

> Today marks the start of the annual ASCO. Here's a round-up of some of the news coming out of the conference. ASCO report

> More from the Web-marketing frontier, where portals and blogs are passé: An Arizona entrepreneur is working up a site where cancer doctors and drugmakers can mix and mingle. Report

> Pharmacy records could soon become an open book in California. Yesterday, the state Senate passed a bill allowing pharmacies to sell patient info to third-party firms working for drugmakers. Report

> Eli Lilly says it's making progress with the FDA on approval of its long-acting, injectable form of Zyprexa. FDA report

And Finally... Solving the mystery of why type 1 diabetes is so prevalent in Finland could be the key to teasing out the causes of the disease. Report

ALSO NOTED: New vaccine/chemo combo effective in cancer study; Type 1 diabetes vaccine goes into human studies; and much more..

Thu, 29 May 2008 06:59:50 -0400

> Chutes & Ladders: Susan Windham-Bannister will take over as CEO of the Massachusetts Life Sciences Center Board. The board's function is to ensure the state retains its prominence in the life science industry. Report

> New trial data shows that the combination of a chemotherapy drug and a new vaccine significantly prolonged the survival of patients with glioblastoma, the aggressive brain cancer that now afflicts Senator Ted Kennedy. Vaccine report

> Denmark's Bavarian Nordic has launched a Phase I/II trial of an experimental HIV vaccine. Safety data from the study is expected by the end of this year with immunogenicity data following in the first half of next year. Report

> Researchers have begun human studies of a new vaccine that is designed to block or reverse type 1 diabetes. A team at Children's Hospital in Pittsburgh is loading microspheres with nucleic acid. Report

> Analysts are chatting up Gilead Science's HIV drug Viread as a treatment for hepatitis B. Report

> FDA is considering new, more detailed drug labeling aimed at pregnant and nursing women. FDA report

And Finally... Remember last month when Merck CEO Dick Clark remarked on Big Pharma's "trust deficit?" Well, here's quantitative evidence of it. A European Commission study found that healthcare professionals and payers are "mostly suspicious" of drugmakers as sources of information about drugs. Report

ALSO NOTED: YM cuts losses;French launch vaccines probe; diabetes foundation contributes research funds; and much more...

Thu, 07 Feb 2008 06:59:50 -0500

> YM Biosciences managed to halve its pre-tax loss for the first half by cutting expenses. Release

> French authorities are investigating GlaxoSmithKline and Sanofi Pasteur over an anti-hepatitis B vaccination campaign in the 1990s. At issue is whether the companies fully disclosed the shot's potential side effects. Report

> The Juvenile Diabetes Research Foundation is giving Plureon $500,000 over two year to research new treatments for type 1 diabetes. Report

> A new blend of a genetically modified chimp adenovirus and a malaria gene is proving promising as a potential vaccine against malaria. Report

> When the American College of Cardiology sent out its annual meeting agenda, the controversial ENHANCE study wasn't listed as a highlighted presentation. Report

> Manhattan Pharmaceuticals has entered into a joint venture agreement with Nordic Biotech Advisors ApS (Nordic) to develop and commercialize Hedrin, the company's novel, non-insecticide treatment for head lice. Release

> Twenty-three people have died after being injected with colchicine, a gout drug that's FDA-approved only for oral use. Report

> A few hours of extreme drowsiness is not a bad trade-off for schizophrenia patients who have problems sticking to their medication. So said an FDA advisory committee yesterday in backing approval of Eli Lilly's new long-acting, injectable form of Zyprexa. Report

> Plummeting Avandia sales have taken a toll on GlaxoSmithKline's bottom line. Report

And Finally… Researchers can now use a transparent zebrafish to help them advance their understanding of disease. Release

Bayhill files IPO papers, hunts for cash

Wed, 09 Jan 2008 06:59:58 -0500

At least one biotech is out to brave the chilly waters of Wall Street. Looking to gin some capital to cover the cost of upcoming clinical trials, Bayhill Therapeutics filed an IPO at least tentatively designed to raise about $86 million. Its experimental therapies are in studies to determine their effectiveness in restoring "tolerance" in immune systems, a new category of drugs with no currently approved therapies on the market. Bayhill has lost $13.5 million in the nine months through September 30, not unexpected in a company with no products on the market. Palo Alto, CA-based Bayhill's lead therapy is for multiple sclerosis with another program for type 1 diabetes.

- read the AP report

ALSO: Italy's Philogen says that regulators have OK'd its IPO. Report

Related Articles:
Bayhill raises $15.8M in VC. Report
M&A activity heats up as biotech IPOs struggle. Report
Biotech IPOs losing their attraction. Report
Deal-making hits a faster pace in '07. Report

GSK, Tolerx forge $760M development pact

Tue, 23 Oct 2007 06:59:58 -0400

Tolerx has scored a Big Pharma partner in its race to develop a monoclonal antibody (MAb) that may protect people from autoimmune disease. Its chief competitor in the race is MacroGenics, which just days ago announced its licensing deal with Eli Lilly for teplizumab. Both companies are advancing an anti-CD3 monoclonal antibody. Tolerx says that its MAb binds to the CD3 receptor on T cells, blocking a function of T-effector cells that cause autoimmune disease. The biotech has struck its deal with GlaxoSmithKline right at the sweet spot in the deal-making calendar: Tolerx has its therapy--otelixizumab--headed into Phase III trials for type 1 diabetes. Mid-stage trials demonstrated its effectiveness in lowering the need for insulin therapy. The therapy has also been studied in two Phase I trials in psoriasis.

Under the terms of the deal, Tolerx gets $70 million in upfront fees, equity and advanced R&D funds, up to $155 million in future development costs, $350 million in scheduled milestones for a successful program and $175 million in sales milestones. As a further sweetener, Glaxo will invest up to $10 million in Tolerx stock when it goes public. Tolerx will be responsible for a late-stage study of the therapy for type 1 diabetes through the biologics license application. Tolerx also keeps an option to co-promote the therapy for type 1 in the U.S. while Glaxo gains exclusive rights to all other indications in the rest of the world.

"Otelixizumab is another welcome addition to GSK's rapidly expanding biopharmaceuticals pipeline. This is a key area of future growth and investment for GSK and, as a novel treatment for many T cell-mediated diseases, the potential of otelixizumab is significant," says Dr. Moncef Slaoui, chairman of research and development at GSK.

- see the release for more info

ALSO: For more on Tolerx and its race with MacroGenics, read this profile.

Related Articles:
Synta scores $1.1B deal with GSK. Report
GSK taps Witty as next CEO. Report
Eli Lilly forges $1B diabetes deal. Report
MAbs are hottest segment of biotech industry. Report

Piglet cells used to treat Type 1 diabetes

Wed, 10 Oct 2007 06:59:57 -0400

Australia's Living Cell Technologies is garnering headlines with some intriguing responses tracked in a tiny diabetes trial undertaken in Russia. Two volunteers were injected with insulin-producing pancreas cells taken from piglets. With the smallest dose, volunteers demonstrated a 25 percent reduction in their insulin requirements. CEO Dr. Paul Tan called the trial results a "breakthrough" in treating Type 1 diabetes. The key to making it work, says the company, is coating the pancreas cells with a gel that prevents them from being marked for destruction by the human immune system and allows them to express insulin. That coating process prevents the need for using immuno-suppressant therapies.

- see the release on LCT's work
- read the report from The Age

Related Articles:
LCT's stem cell research should be encouraged. Editorial
Diabetes epidemic triggers soaring drug market. Report

Read more on: Type 1 Diabetes

Press Release: MicroIslet Implements Staffing Changes to Further the Company's New Corporate Strategy

Mon, 23 Jul 2007 12:57:54 -0400

MicroIslet Implements Staffing Changes to Further the Company's New Corporate Strategy SAN DIEGO, July 23, 2007 -- As previously announced, MicroIslet has refocused its efforts to accelerate the clinical testing of the Company's ``MicroIslet-P(tm)'' encapsulated islet preparation in persons suffering from Type 1 diabetes. In a first clinical phase, MicroIslet intends to initiate xenograft clinical trials in locations outside of the United States. As part of this strategy, the Company has recently implemented changes to both its management and Board of Directors. A second phase of this approach has now been initiated, and includes a shift in developmental expenditures and personnel. Accordingly, MicroIslet has decided to use outside facilities that operate under Good Manufacturing Practices (GMP) for islet isolation and encapsulation. These functions were previously performed in-house in non-GMP facilities, which was acceptable for preclinical development but not for human transplantation. MicroIslet also intends to refocus R&D efforts on finalizing its existing encapsulation technology for human transplantation. The Company is also exploring strategic partnership opportunities that may expedite and advance human clinical testing, both abroad and in the United States. The Company expects to make announcements regarding GMP facilities and other strategic partnerships later in the year. The current management and Board are extremely grateful to the employees who have made this a very smooth transition period. ADVERTISEMENT ``On behalf of the management and Board of Directors, I want to extend our deep appreciation to the departing employees of MicroIslet. In any change of strategy, difficult staffing decisions have to be made, and such was the case here. The ultimate goal of MicroIslet, a transplantation therapy for diabetic patients, remains one of the most important and overdue advances in medicine. I am confident that our new direction will add to the existing foundations of excellence built by the employees of MicroIslet,'' said Michael J. Andrews, CEO. About MicroIslet: MicroIslet is a biotechnology company engaged in the research, development, and commercialization of patented technologies in the field of transplantation therapy for people with conditions requiring cell-based replacement treatments, with a focus on type 1, or insulin dependent diabetes. MicroIslet's patented islet transplantation technology, exclusively licensed from Duke University, along with its own developments, constitute methods for isolating, culturing, cryopreservation, and immuno-protection (microencapsulation) of islet cells. MicroIslet intends to continue its research and development efforts, and ultimately, to introduce products to the market. Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the ``safe harbor''' provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including MicroIslet's need to raise substantial additional funds in order to fund its new strategy and continue as a going concern, the risks and uncertainties inherent in medical treatment discovery, development and commercialization, the risks and uncertainties associated with MicroIslet's early stage xenotransplantation technologies, the risks and uncertainties of governmental approvals and regulation, including foreign government approvals for clinical trials outside the United States, dependence on FIOS Therapeutics as a sole source supplier of animal parts for pre-clinical and clinical studies, the risks and uncertainties associated with third-party outsourced manufacturing and strategic partnerships, including the need to identify and negotiate terms with such entities, the risks that MicroIslet's competitors will develop or market technologies or products that are more effective or commercially attractive than MicroIslet's products, and other risks detailed from time to time in MicroIslet's most recent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. MicroIslet disclaims any intent or obligation to update these forward-looking statements.

Press Release: FDA Approves Novo Nordisk NovoLog Category Change For Use In Pregnant Women With Type 1 Diabetes

Maureen Martino — Tue, 30 Jan 2007 11:23:06 -0500

FDA Approves Novo Nordisk NovoLog Category Change For Use In Pregnant Women With Type 1 Diabetes

PRINCETON, N.J., Jan. 30 -- Novo Nordisk announced today that the United States Food and Drug Administration (FDA) has approved NovoLog® (insulin aspart [rDNA origin] injection) for pregnancy Category B rating, further validating NovoLog® as a safe and effective treatment for pregnant women with Type 1 diabetes and their unborn children.

Diabetes and its treatment options can present significant challenges for women wishing to conceive and have a healthy pregnancy. As a safety precaution, the FDA classifies prescription drugs with specific category ratings to provide decision-making guidelines for physicians treating pregnant women. The Pregnancy Category B rating for NovoLog® indicates that adequate studies in pregnant women with Type 1 diabetes have demonstrated that NovoLog® does not increase risk to the unborn baby. Previously, NovoLog® was classified as a Category C rating, which indicates that adverse effects on the fetus have been demonstrated in animal reproduction studies, and that adequate and well-controlled studies in pregnant women have not been conducted to demonstrate safety(1).

"While clinical research is rarely conducted in pregnant women, we at Novo Nordisk understand the needs of this special population. The confirmed safety of NovoLog® will allow their doctors to make informed decisions about treatment options for people with diabetes," said Martin Soeters, president of Novo Nordisk. "We are excited that the FDA has acknowledged our efforts to advance diabetes treatment and recognizes the value of our insulin analogs such as NovoLog®."

The FDA category change was based on a review of the largest ever randomized controlled trial using an insulin analog in pregnant women with type 1 diabetes.

The study, conducted at 63 sites in 18 countries, compared the safety and efficacy of NovoLog® versus human regular insulin (HRI) in the treatment of 322 pregnant women with type 1 diabetes. Data demonstrated that changes in HbA1c and rates of maternal hypoglycemia were comparable with NovoLog® compared to HRI. The study was not large enough to evaluate the risk of congenital malformations. Compared to HRI, the trial with NovoLog® showed improved outcomes for both mother and child in terms of:

-- Fewer preterm deliveries (p<0.053) -- Reduced risk of neonatal hypoglycemia (glucose <2.6 mmol/L) requiring treatment -- Consistently low rates of major hypoglycemia -- Reduced risks to the fetus, with outcomes at least comparable to HRI(2).

Diabetes and Pregnancy Each year in the US, about 18,000 women with pre-existing type 1 or type 2 diabetes(3) become pregnant and 135,000 pregnant women develop gestational diabetes (those who develop high blood sugar during pregnancy(4)). For these pregnant women, insulin is frequently used to manage their diabetes(5).

Diabetes that is not tightly controlled can lead to extensive complications for mother and baby and can cause significant burdens on families and the healthcare system(6):

-- For the mother, complications from existing diabetes may worsen and new complications may emerge(7), including greater incidence of miscarriage, high blood pressure, kidney disease and nerve damage(8).

-- For the baby, uncontrolled diabetes may mean up to four-times more likelihood of being born with increased infant mortality, preterm birth (and the myriad of problems associated with it), high birth weight(9) or a birth defect(10).

Chances of these complications are lower when women have good glycemic control(11). However, only 40-60 percent of women with pre-existing diabetes achieve optimal glycemic control while pregnant(12).

About NovoLog®

NovoLog® is a rapid-acting form of insulin for the treatment of people with diabetes mellitus for the control of hyperglycemia. It enters the bloodstream quickly and begins working within minutes to lower blood glucose. The rapid onset and short duration of action mimic the insulin action of a person without diabetes. NovoLog® offers convenient mealtime dosing and should be administered before a meal (start of meal within 5 to 10 minutes after injection). NovoLog is available in the prefilled NovoLog® FlexPen® insulin delivery system.

NovoLog® is contraindicated during episodes of hypoglycemia and in people hypersensitive to insulin aspart or one of its excipients. Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog®. See package insert for more details. NovoLog® was originally approved by the FDA for use in adults in the U.S. in 2000.

Because it has a more rapid onset and shorter duration of action than regular human insulin, NovoLog® should normally be used in regimens together with an intermediate or long-acting insulin, and injection of NovoLog® should immediately be followed by a meal.

Any change in insulin should be made cautiously and only under medical supervision.

Prescribing information for NovoLog is available by contacting Novo Nordisk or by visiting novonordisk-us.com.

Novo Nordisk is a healthcare company with an 80-year history of innovation and achievement in diabetes care. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs more than 23,000 employees in 79 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For global information, visit novonordisk.com; for United States information, visit novonordisk-us.com.

(1) "Current Categories for Drug Use in Pregnancy," FDA (2006). http://www.fda.gov/fdac/features/2001/301_preg.html#categories

(2) Data on file at Novo Nordisk Inc.

(3) Centers for Disease Control and Prevention. Preventing Diabetes and Its Complications. Available at http://www.cdc.gov/nccdphp/publications/factsheets/Prevention/diabetes.htm. Accessed November 8, 2006.

(4) American Diabetes Association. Gestational Diabetes. Available at http://www.diabetes.org/gestational-diabetes.jsp. Accessed November 8, 2006. (5) "Diabetes in Pregnancy," March of Dimes (2006). http://www.marchofdimes.com/professionals/681_1197.asp (6) Lanham, MD: "The Diabetes in Pregnancy Dilemma: Leading Change with Proven Solutions, University Press," Journal of the American Medical Association book review (9/27/2006). (7) "Pregnancy and Diabetes Frequently Asked Questions," Centers for Disease Control (2006). (8) "Diabetes and Pregnancy Frequently Asked Questions," (2006), Centers for Disease Control. http://www.cdc.gov/ncbddd/bd/diabetespregnancyfaqs.htm (9) Ibid. (10) "High Blood Glucose Levels in Early Pregnancy May Deprive Embryo of Oxygen and Lead to Birth Defects, Joslin Diabetes Center Study Shows," (2005) Joslin Diabetes Center http://www.hms.harvard.edu/news/pressreleases/jos/0905bloodglucose.html (11) "Diabetes and Pregnancy," Organization of Teratology Services (2006). http://otispregnancy.org/pdf/diabetes.pdf (12) Lanham, MD: "The Diabetes in Pregnancy Dilemma: Leading Change with Proven Solutions, University Press," Journal of the American Medical Association book review (9/27/2006).

Novocell scientists create insulin-producing cells

Thu, 19 Oct 2006 20:01:38 -0400

Novocell has managed to turn embryonic stem cells into insulin-producing pancreatic cells, a major step in a long journey toward curing patients with Type 1 diabetes. Vanderbilt's Dr. Mark A. Magnuson told The New York Times that Novocell's scientists had reached an efficiency of cell conversion that was in "orders of magnitude higher than anything previously accomplished." But he noted that significantly more work needs to be done. Novocell's scientists took embryonic stem cells and tweaked them with growth factors, mimicking the process in the creation of pancreatic cells. Novocell still has a considerable amount of testing to do. Animal studies are planned in '08, with human trials scheduled to get underway in '09. And that's the best-case scenario.

"The efficient, reproducible production of human embryonic stem cell-derived, insulin-producing endocrine cells through a process that mirrors the development of human pancreatic cells represents a critical step toward providing a renewable source of cells for diabetes therapy," said Emmanuel Baetge, Ph.D., chief scientific officer of Novocell and senior author of the publication. "This provides a foundation upon which we can build a standardized process for generating functional insulin-producing cells for the treatment of diabetic patients."

- read the report on the research from The New York Times

VC: Ablynx lands $50M in VC

Wed, 23 Aug 2006 20:01:32 -0400

Ablynx lands $50M in VC

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Ablynx Ghent, Belgium	$50M Third	KBC	Ablynx will now be able to fund operations through to at least mid-2008, allowing the company to further develop its product pipeline based on its Nanobody technology and to rapidly increase its head count.
Intranasal Therapeutics (ITI) Lexington, KT	$39.1M First	SV Life Sciences	The funding will be used to launch a hydromorphone nasal spray for acute pain that is currently in Phase II/III testing. press release
TolerRx Cambridge, MA	$35.6M Unknown	FrontPoint Partners	The funds will support the clinical development of TolerRx's lead product, TRX4, an anti-CD3 monoclonal antibody in development for Type 1 diabetes and psoriasis.
Kemia San Diego, CA	$31M Third	Aberdare Ventures	The company plans to use the proceeds to advance its lead clinical compound, KC706, through initial Phase II clinical trials.
Thiakis United Kingdom	$19M First	Novo A/S and Advent Venture Partners	The company is focused on the development of peptide hormones for the treatment of obesity.
Cempra Pharmaceuticals Morrisville, NC	$14M First	Intersouth Partners and I. Wistar Morris III	Cempra will advance its pipeline of antibiotics.
LipoScience Raleigh, NC	$13M Sixth	Camden Partners, GE Capital Equity Investments, INVESCO Private Capital, Pappas Ventures, Sightline Partners, Three Arch Partners, and Varian	The funding will allow LipoSciences to invest in the deployment of the in-vitro diagnostic system.
Accera Broomfield, CO	$7.5M Round	Inventages Venture Capital	Most of the money will go to two mid-stage trials.
4-Antibody Switzerland	$6M First	Biomedinvest, Grazia Equity, Life Science Partners and Mulligan Biocapital	4-Antibody will move forward pursue internal and collaborative development projects for fully human antibodies.

VC: Cempra pockets $14M in round one

Tue, 15 Aug 2006 20:01:37 -0400

Upstart Cempra Pharmaceuticals has raised $14 million in new venture capital to advance its pipeline of antibiotics. This Morrisville, NC-based biotech has proven to be a fast mover, inking a licensing deal with Optimer for macrolides and ketolides, which fight macrolide-resistant bacteria. Intersouth Partners and investor I. Wistar Morris III co-led the first round, which followed angel financing.

"We believe that Cempra is positioned to make significant breakthroughs in macrolides that will serve thousands of patients every year," Intersouth's Garheng Kong said in a statement. "The company's proprietary chemistry platform will enable a series of macrolides previously unavailable. We're excited to be working with Cempra to develop this important class of drugs."

- check out the report on Cempra from LocalTechWire

PLUS: Cambridge, MA-based TolerRx has raised $35.6 million to advance its lead product--TRX4--for Type 1 diabetes. The Juvenile Diabetes Research Foundation contributed part of the funds. Release

ALSO: LipoScience has raised $13 million in fresh venture capital, largely to advance new products and promote its NMR LipoProfile, which measures lipoprotein particles in the blood. Report

VC: Aerovance lands $60M in VC

Wed, 17 May 2006 20:01:32 -0400

Aerovance lands $60M in VC

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Aerovance Berkeley, CA	$60M Third	Clarus Ventures	The funding will be used to get the company's two lead products through proof-of-concept studies.
Nanosphere Northbrook, IL	$57M Fourth	Bain Capital	The capital will be used to commercialize a new and more efficient method for gene and protein testing.
MacroGenics Rockville, MD	$45M Third	Ventures West	MacroGenics' lead product is slated for a Phase II/III trial to begin later this year for Type 1 diabetes. The company also has earlier-stage prospects for cancer and autoimmune diseases.
Avidia Mountain View, CA	$43.8M Third	Skyline Ventures	Much of the money will go to fund studies of an inhibitor of interleukin 6 for the treatment of inflammation and autoimmune disease and an inhibitor of IgE.
Viron Therapeutics Canada	$20M First	Canadian Medical Discoveries Fund	The funds will finance the company's operations through to the end of 2008.
Onyvax London, England	$14.7M Third	3i and SR One	The funds raised will be used to advance the development of Onyvax-P, the firm's lead product for the treatment of prostate cancer.
D-Pharm Israel	$10M	Clal Biotechnology Industries, Israel Healthcare Ventures and Pitango Venture Capital	D-Pharm is currently in Phase IIb with an experimental drug for strokes and is also developing therapies for brain disorders and epilepsy.

MacroGenics garners $45M in third round

Tue, 16 May 2006 20:01:36 -0400

Rockville, MD-based MacroGenics has raised $45 million in its third round of venture capital, bringing its total venture haul to date to $106 million. The Canadian venture group Ventures West led the round. MacroGenics' lead product is slated for a Phase II/III trial to begin later this year for Type 1 diabetes. MacroGenics also has earlier-stage prospects for cancer and autoimmune diseases. The biotech has 70 workers with plans to expand.

- here's the Washington Business Journal article on the round

Bayhill raises $15.8M in VC

Mon, 10 Apr 2006 20:01:35 -0400

Bayhill Therapeutics, a company focused on autoimmune diseases, has raised $15.8 million in series B funding for a total round of $51.2 million. "Acknowledging success of BHT-3009, the first drug candidate from Bayhill's antigen-specific platform, current investors paid additional funds into Bayhill to advance its second antigen-specific drug candidate, BHT-3021 for Type 1 diabetes, into Phase I/II human clinical trials," said Mark W. Schwartz, Ph.D., President and CEO, Bayhill Therapeutics. The company also announced that it has begun dosing patients in a Phase II trial of with BHT-3009, a multiple sclerosis treatment.

- see the company's press release

PLUS: Vancouver-based Xenon Pharmaceuticals has raised $31 million in funding. The round was led by MX Associates and LipoteRx and will support the the growth of Xenon's clinical programs. Xenon focuses on neurological, cardiovascular and metabolic diseases. Release

ALSO: Theranox has raised over $14 million in Series A financing to fund clinical trials and commercialize the use of gaseous nitric oxide for the treatment of chronic wounds. The round was led Quaker BioVentures and NewSpring Capital. Release

ALSO NOTED: BioMarin to raise $267M; FDA rejects King's Altace; and much more...

Thu, 23 Mar 2006 19:00:50 -0500

> BioMarin Pharmaceutical is selling $267 million in shares and notes. The Novata, CA-based biotech announced the move about a week ago, saying it would use the funds both to market existing therapies as well as research new ones in clinical trials. The offering comes fast on the heels of positive data for Phenoptin, a treatment for an ezyme-deficiency disorder. Report

> The FDA rejected King Pharmaceuticals' application to gain approval for its high blood pressure drug Altace for children. King says it will undertake a second clinical trial for the pediatric indication, primarily so it can extend its patent protection. Report

> The FDA has put an early human trial of Encysive's TBC3711 on hold after a rat in an animal study showed signs of abnormalities. Report

> CancerVax revealed Phase III data that showed the failure of Canvaxin to demonstrate efficacy. CancerVax discontinued its Phase III of Canvaxin last October. Report

> Sanofi-Aventis says that an EU committee has recommended Taxotere for advanced stomach cancer, a day after receiving the FDA's OK. Report

> The EMEA has again rejected Novartis' irritable bowel therapy Zelnorm. Report

> YM BioSciences has enlisted its first patient in a Phase I/II non-small-cell lung cancer trial utilizing YM's anti-EGFr monoclonal antibody, nimotuzumab (TheraCIM). Release

> ACADIA Pharmaceuticals reported positive results from its Phase II clinical trial of ACP-103 in patients with Parkinson's disease suffering from treatment-induced psychosis. Release

And Finally…Three groups of scientists have confirmed that severely diabetic mice were able to recover after researchers halted an immune reaction that causes the disease. The news offers hopes of a cure for patients with Type 1 diabetes. Article

Neurocrine Phase II flunks endpoint

Tue, 07 Mar 2006 19:01:38 -0500

Shares of Neurocrine Biosciences slipped after it announced that a Phase II trial of its altered peptide ligand technology for multiple sclerosis failed to hit its primary endpoint. Researchers said they would dump the APL-MS work but complete its other APL Phase II study, which is evaluating the APL technology for the treatment of Type-1 diabetes utilizing a different APL epitope.

"Neurocrine is continuing to focus its resources on several new product candidates which are currently advancing through development, and we will report on these Phase II and proof-of-concept results throughout this year," said Wendell Wierenga, Ph.D, executive vice president of research and development for Neurocrine Biosciences.

- here's the report from the San Diego Daily Transcript

Transplant drugs may offer Type 1 help

Tue, 07 Mar 2006 19:01:37 -0500

The Wall Street Journal examines some of the new clinical research work being done on immunosuppressants to treat Type 1 diabetes. Researchers haven't come up with a significant new therapy for Type 1 since the 1920s, but drugs like Roche's Daclizumab may offer some major improvements for patients. Just as immunosuppressants work to help patients' bodies avoid rejecting new organs, this method may help stop the immune system from attacking insulin-producing beta cells in the pancreas.

- here's The Wall Street Journal article (sub. req.)

TolerRx gains orphan status for diabetes drug

Mon, 13 Feb 2006 19:01:35 -0500

The FDA has given TolerRx's lead product, TRX4, orphan drug status for the treatment of new-onset Type 1 diabetes. If approved, Cambridge, MA-based TolerRx would gain a seven-year exclusive for the therapy. About 1.3 million people suffer from Type 1 diabetes in the U.S.

- read this report from MassHighTech